This chapter describes the procedure that should be used for the design of orthopaedic devices. The design of such devices is controlled by regulatory authorities in most countries, such as by the FDA GMP requirements and in the EU by EU Directive MDD 93/42/EC. Except for minor design changes design must be carried out following a detailed design plan with the activities associated with the plan well documented. The design process usually begins when a design opportunity is identified. After feasibility is determined a design plan is formulated with inputs from reglatory affairs and patent expertise. Design requirements are established and usually, at least one, preliminary design developed and evaluated. Final design can then be developed through a feed-back process of redesign and reevaluation. The final design must then be verified through appropriate analysis and testing. The design and associated manufacturing capability must be then validated before release for producion. This process must be documented in the Design History Files.
KeywordsEuropean Union Preliminary Design Post Market Surveillance Design Plan Design Review
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